FDA says it has not been able to establish a causal connection between suicidal ideation and drugs like Ozempic and Wegovy and is continuing to review...
Four major stakeholder groups air their disagreement with an FDA revised draft guidance on firms communicating scientific information on unapproved us...
FDA clears a Zeta Surgical 510(k) for its Zeta Cranial Navigation System.
Busse Hospital Disposables recalls its Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in response to Nurse Assists 11/2023 re...
Federal Register notice: FDA makes available a draft guidance entitled Requests for Reconsideration at the Division Level Under GDUFA.
Federal Register notice: FDA sends to OMB an information collection revision entitled Electronic Records; Electronic Signatures 21 CFR Part 11.
FDA warns South Koreas Woorilife & Health about CGMP violations in its manufacturing of over-the-counter drugs.
FDA warns Ichibancho, Japan-based Neitz Instruments Company about Medical Device Reporting violations in its manufacturing of its halogen ophthalmosco...
